Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 3:27 AM
Ignite Modification Date: 2025-12-26 @ 2:08 AM
NCT ID: NCT04467905
Description: An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product that did not necessarily have a causal relationship with the product. Untreated participants were not included in safety or efficacy analyses (were not included in safety or efficacy populations).
Frequency Threshold: 5
Time Frame: 7 days. Adverse events were monitored from Screening until study participation was complete after the final Follow-Up.
Study: NCT04467905
Study Brief: ReVeRA-201: Etripamil in Atrial Fibrillation, Phase 2
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Administration of placebo at the emergency department for an episode of atrial fibrillation Placebo: The formulation of placebo nasal spray consists of water, sodium acetate, disodium, disodium ethylene-diamine-tetra-acetic acid (EDTA), and sulfuric acid to reproduce the same pH as the etripamil formulation. 0 None 4 29 18 29 View
Etripamil Administration of 70 mg etripamil at the emergency department for an episode of atrial fibrillation Etripamil: The formulation of etripamil nasal spray consists of MSP-2017 (etripamil), water, acetic acid, disodium ethylene-diamine-tetra-acetic acid (EDTA), and sulfuric acid. The dose of etripamil to be evaluated in this study is 70 mg. 0 None 1 27 23 27 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Intracardiac thrombus SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v 23.1 View
Peripheral artery occlusion SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v 23.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v 23.1 View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v 23.1 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v 23.1 View
Bradyarrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v 23.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v 23.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Intracardiac thrombus SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v 23.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v 23.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v 23.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v 23.1 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v 23.1 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v 23.1 View
Nasal discomfort SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v 23.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v 23.1 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v 23.1 View
Throat irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v 23.1 View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA v 23.1 View
Bradyarrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA v 23.1 View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v 23.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v 23.1 View